Perspectives on Enquiry & Evidence

As of today, our Industry has not defined any approach, nor does an official regulatory agency..

In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM...

The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a..

Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit..

The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all..

When an expert statistician is paired with an experienced set of data managers, opportunities to capitalize on..

About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO..

In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his..

A credible evidence base is needed to support and document the economic value of new technologies and therapeutic..